A Phase I/II Study of GX15-070MS in Untreated CLL

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

A Multi-Center, Open-Label, Phase I/II Study of Single-Agent GX15-070MS Administered Every 2 to 3 Weeks to Patients With Previously-Treated Chronic Lymphocytic Leukemia (CLL)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00600964
• Other study ID #: GX004
• Status: Completed
• Phase: Phase 1
• First received: January 15, 2008
• Last updated: May 9, 2014
• Start date: September 2004
• Est. completion date: January 2006

Study information

• Verified date: May 2014
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

This protocol is being run to determine the best phase II dose and schedule of obatoclax in patients with previously untreated CLL.

Description:

Both 1 hour and 3 hour infusions of obatoclax every 3 weeks will be evaluated in ascending doses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: January 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically or cytologically confirmed B-CLL

• Previous standard systemic chemotherapy, including fludarabine. There are no limitations on additional, allowable type and amount of prior therapy. Acute toxicities from prior therapy must have resolved to =Grade 1

• Age =18 years

• ECOG Performance Status =1

• Life expectancy of >8 weeks

Exclusion Criteria:

• Patients receiving any other investigational agents (e.g., under another IND) or commercial agents or therapies administered with the intent to treat their malignancy

• Patients with history of seizure disorders

• Pregnant women and women who are breast feeding

• HIV-positive patients receiving combination anti-retroviral therapy

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• GX15-070MS
A 60-minute or 3-hour IV infusion every 2-3 weeks.
• GX15-070MS
GX15-070MS at various doses and schedules

Locations

Country	Name	City	State
Canada	Princess Margaret Hospital	Toronto	Ontario
United States	Milton S Hershey Medical Center Penn State Cancer Institute	Hershey	Pennsylvania
United States	UT MD Anderson Cancer Center	Houston	Texas
United States	University of CA- San Diego	La Jolla	California
United States	Lombardi Cancer Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Gemin X

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

O'Brien SM, Claxton DF, Crump M, Faderl S, Kipps T, Keating MJ, Viallet J, Cheson BD. Phase I study of obatoclax mesylate (GX15-070), a small molecule pan-Bcl-2 family antagonist, in patients with advanced chronic lymphocytic leukemia. Blood. 2009 Jan 8;1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the recommended Phase II dose of GX15-070MS administered as a 60-minute and/or 3-hour infusion every 2 to 3 weeks		14 days	Yes
Secondary	Estimate the response rate of previously-treated patients with CLL at the recommended Phase II dose of GX15-070MS administered as a 60-minute and/or 3-hour infusion every 2 to 3 weeks.		14 days	Yes